Every recall we track for Paragon 28, Inc. — 13 in all — plus the complaints and injury reports the public filed about them.
Paragon 28 recalls a specific foot implant model due to elevated oxygen levels potentially reducing material strength. Affected units include Lot AOCIA6123.
Paragon 28 recalls a specific foot implant model due to potential oxygen level issues that could reduce material strength. Affected units include the 6123S R model with lot number AOCIA6123.
Paragon 28 recalls P28 Phantom Hindfoot Nail System due to potential sterile packaging breaches. Affected units have specific model and lot numbers. Consumers should check their product details and contact the company for guidance.
Paragon 28 recalls Phantom Fibula Nails with improper thread depth that could require surgery abortion. Affected items have specific model and lot numbers. Contact for remedy.
Paragon 28 recalls Phantom TTC Nails (10.0 X 200mm, Right) distributed before sterilization. This medical device may not be safe for use.
Paragon recalls Phantom TTC Nails distributed before sterilization. These medical devices may not be sterile, posing infection risks. Consumers should contact Paragon for details.
Paragon 28 recalls Phantom TTC Nails distributed before sterilization. These medical devices pose a risk of infection due to improper sterilization. Affected units include specific model and reference numbers.
Paragon 28 recalls titanium suture anchors that may break during surgery, causing debris and delays. Affected kits include REF P44-110-3010-SK. Contact for return instructions.
Paragon 28 recalls HammerTube Implant 2.75mm cannulated (sterile) due to missing titanium coating. Affected units have specific part numbers and lot numbers. Consumers should contact for details.
Paragon 28 recalls Baby Gorilla/Gorilla Plating System (Ref: P99-100-2816) due to potential incorrect part numbers in drill packaging. Affected units may have wrong labels.
Paragon 28 recalls Phantom Nail System Drills with thin wall condition that may fracture, risking injury. Affected models include P99-110-4630.
Paragon 28 recalls 10mm wedge implant kits labeled as 12mm to prevent surgical errors. The mislabeling risks improper surgical site preparation and delays in procedures.
Paragon 28 recalls JAWS Nitinol Staple System kits for foot bone repairs due to missing drill guide in some models. Affected kits include specific part numbers and production lots. Consumers should check their kit details and contact Paragon 28 for guidance.
